Drugs

Bipartisan Animal Testing Reform Bill

A bipartisan group of House members is introducing legislation dubbed FDA Modernization Act 3.0 to require the agency to implement animal testing reforms that Congress approved over a year ago. In a statement, Animal Wellness Action, the Center for a Humane Economy, and Animal Wellness Foundation said the 2022 legislation eliminated an animal-testing mandate that had been in place since the 1930s, giving drug sponsors the option to use innovative 21st-century human-biology-based methods instead.

FDA Modernization Act 3.0 would require the agency to publish a final rule to implement the FDA Modernization Act 2.0 and establish clear guidelines for non-animal test methods that can better predict drug safety and efficacy, and speed the time to market for new treatments and cures.

The bill was introduced by Reps. Buddy Carter (R-GA), Nanette Barragán (D-CA), Diana Harshbarger (R-TN), and Rosa DeLauro (D-CT), with seven additional bipartisan cosponsors.

The statement says that FDA’s failure to act in more than 13 months “is baffling, given the widespread support for the FDA Modernization Act 2.0 both in the scientific community and among biotech companies and drug developers. More than 450 global publications, including news articles, commentaries, scientific reviews, and primary papers, have been published since enactment and noted the potential for a paradigmatic shift in drug development.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome